(133 days)
No
The device description details a standard ELISA assay, which is a biochemical test. There is no mention of AI or ML in the device description, intended use, or performance studies. The performance studies describe standard statistical analysis of assay results.
No
This device is an in vitro diagnostic (IVD) test kit used to detect antibodies for diagnostic purposes, not to treat a disease or condition.
Yes
The device is intended as a qualitative test for the detection of IgM antibodies to B. burgdorferi, which is used to support the diagnosis of Lyme disease.
No
The device is a laboratory test kit containing physical reagents and components for performing an ELISA assay, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "qualitative test for the detection of IgM antibodies to B. burgdorferi sensu stricto in human serum". This indicates it's used to examine a sample taken from the human body (serum) to provide information about a medical condition (presence of antibodies to the cause of Lyme disease).
- Device Description: The description details a laboratory test kit with reagents and controls designed to perform an ELISA (Enzyme-Linked Immunosorbent Assay) on human serum samples. This is a standard method for in vitro diagnostic testing.
- Performance Studies: The document includes extensive performance studies, including nonclinical and clinical studies, comparing the device to predicate devices and evaluating its sensitivity, specificity, and agreement with clinical diagnoses. This type of testing and validation is characteristic of IVD devices.
- Predicate Devices: The mention of predicate devices (K894293 and K113846) which are also IVD test kits further confirms the nature of this device.
Therefore, based on the intended use, device description, and the context of the provided information, the Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit is intended as a qualitative test for the detection of IgM antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. When used as the first-tier screening test, positive and equivocal results must be supplemented through additional testing by one of the following methods:
· Standard two-tier test methodology (STTT) using an IgM blot test following current interpretation guidelines, OR
• Modified two-tier test methodology (MTTT) using the Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/ IgM ELISA Test.
The assay can also be used as a second-tier confirmation test using the MTTT methodology when used with the Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test as the first-tier screening test.
Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory findings.
Product codes
LSR
Device Description
The kit includes 12 x 8 well Antigen Coated strips. Conjugate. Substrate, Stop Solution, Wash Buffer, Diluent, Negative Control, Positive Control, and Cutoff Control. The controls are provided to determine if the assay is functioning properly and to determine the antibody level. The reagents are sufficient for 96 determinations.
During the test procedure, antibodies to B. burgdorferi (sensu stricto) if present in the human serum sample will bind to the antigens coated onto the wells forming antigen-antibody complexes. Excess antibodies are removed by washing. A conjugate of goat anti-human IgM antibodies conjugated with horseradish peroxidase is then added, which binds to the antigenantibody complexes. Excess conjugate is removed by washing. This is followed by the addition of a chromogenic substrate, tetramethylbenzidine (TMB). If specific antibodies to the antigen are present in the patients' serum, a blue color will develop. The enzymatic reaction is then stopped with a stopping solution causing the contents of the well to turn yellow. The wells are read photometrically with a microplate reader at 450nm.
The antigens used in the Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test kit is a combination of B. burgdorferi sensu stricto strain B31 lysate, B. burgdorferi sensu stricto strain 2591 lysate, and a recombinant VlsE from B. burgdorferi sensu stricto strain B31. The lysates use spirochetes growing in BSK-H complete medium until mid-exponential phase. The recombinant VlsE protein is produced in E. coli SURE2 cells and purified by affinity chromatography. The purity of each antigen is assayed by SDS-PAGE followed by Coomassie staining and/or Western blotting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Studies:
- Determination of the Assay Cutoff:
- Sample Size: 208 normal sera (103 from endemic region, 105 from non-endemic region). An additional 194 samples (114 different phases of Lyme disease, 8 negative healthy samples, 72 negative Lyme disease samples with other cross-reactive diseases).
- Key Results: Cutoff determined using mean plus two standard deviations. ROC analysis performed to confirm cutoff provided best compromise between sensitivity and specificity.
- Precision:
- Study Type: Within-lab precision study.
- Sample Size: Panel consisting of negative, high negative, low positive, and moderate positive samples, and kit controls. Each tested in duplicate, twice per day, for 12 days (N=48 for each sample).
- Key Results: Summarized in tables for Standard Deviation and Coefficient of Variation.
- Reproducibility:
- Study Type: Reproducibility study at three different sites.
- Sample Size: Panel consisting of negative, high negative, low positive, and moderate positive samples, and kit controls. Each tested in triplicate, twice per day, for five days (N=90 for samples, N=30 or N=60 for controls).
- Key Results: Summarized in tables for Within-Run, Between-Run, Between-Days, Between-Sites, and Total Standard Deviation and Coefficients of Variation.
- Analytical Specificity:
- Study Type: Analytical specificity determination.
- Sample Size: 208 asymptomatic individuals' samples (endemic and non-endemic regions).
- Key Results: Endemic Region: 96.1% (4 positive/equivocal out of 103). Non-endemic Region: 90.5% (10 positive/equivocal out of 105).
- Cross Reactivity:
- Study Type: Evaluation of potential cross reactivity.
- Sample Size: 277 samples from different disease conditions.
- Key Results: Some cross-reactivity observed with Ehrlichiosis IgM (60%), Babesiosis IgM (63%), Leptospirosis IgM (80%), and Varicella Zoster Virus (38%). These were also positive on the predicate device for Ehrlichiosis, Babesiosis, and Leptospirosis.
- Interfering Substances:
- Study Type: Evaluation of effect of potential interfering substances.
- Sample Size: Three samples (high negative, equivocal, low positive) spiked with high levels of interferants.
- Key Results: No effect on performance from Albumin, Bilirubin, Cholesterol, Hemoglobin, Triglycerides.
Clinical Studies: Comparison with Predicate Device
- Study Type: Comparison studies at three sites (one internal, two external reference labs).
- Sample Size: 531 serum samples.
- Key Results:
- Positive percent agreement = 90.3% (93/103) with 95% CI (82.9% - 95.5%).
- Negative percent agreement = 99.6% (460/462) with 95% CI (98.5% - 99.9%).
- Second-Tier Testing:
- Study Type: Comparison of second-tier testing results against an FDA cleared IgM blot assay.
- Sample Size: All positive and equivocal samples from the 531 serum comparison study (103 from predicate IgM ELISA, 103 from Gold Standard Diagnostics IgM ELISA Test Kit, 93 for both).
- Key Results: 2nd Tier PPA = 98.3% (58/59) with 95% CI (90.9% - 99.9%).
Clinical Sensitivity
- Sensitivity Study:
- Study Type: Sensitivity study on clinically characterized samples.
- Sample Size: 114 clinically characterized samples (early, disseminated, late stages of Lyme disease).
- Key Results:
- Early Stage: Gold Standard Diagnostics 75.9% (44/58), Predicate 77.6% (45/58).
- Disseminated: Gold Standard Diagnostics 100.0% (17/17), Predicate 100.0% (17/17).
- Late: Gold Standard Diagnostics 89.7% (35/39), Predicate 84.6% (33/39).
- CDC Panel:
- Study Type: Testing against a masked characterized serum panel from the CDC.
- Sample Size: 280 positive and negative specimens from CDC.
- Key Results:
- Healthy: Gold Standard Diagnostics 93.0% agreement, Predicate 86.0% agreement.
- Early Lyme: Gold Standard Diagnostics 76.7% agreement, Predicate 80.0% agreement.
- Cardiac Lyme: Gold Standard Diagnostics 66.7% agreement, Predicate 66.7% agreement.
- Neurological Lyme: Gold Standard Diagnostics 100.0% agreement, Predicate 100.0% agreement.
- Late: Gold Standard Diagnostics 85.0% agreement, Predicate 85.0% agreement.
- Look-alike Disease: Gold Standard Diagnostics 81.1% agreement, Predicate 72.2% agreement.
MTTT Comparison:
- Method Comparison Study – MTTT IgM (Prospective Study):
- Study Type: Comparison of MTTT (2-ELISA) protocol against STTT using predicate IgM blot.
- Sample Size: 481 serum samples tested Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test. 68 positive and equivocal samples were then run on predicate IgM blot (STTT) and Gold Standard Diagnostics VlsE-OspC IgG/IgM ELISA (MTTT).
- Key Results:
- Comparison of second-tier tests: Negative percent agreement = 58.3% (28/48) with 95% CI (43.2% - 72.4%).
- Comparison of overall MTTT vs STTT (all 481 samples):
- Positive percent agreement = 100.0% (20/20) with 95% CI (83.2% - 100.0%).
- Negative percent agreement = 95.7% (441/461) with 95% CI (93.4% - 97.3%).
- Sensitivity Study (MTTT):
- Study Type: Sensitivity study on clinically characterized samples for MTTT-IgM.
- Sample Size: 125 clinically characterized samples (early, disseminated, late stages of Lyme disease).
- Key Results:
- Early Stage: Gold Standard Diagnostics MTTT-IgM 62.9% (39/62), Predicate STTT-IgM 64.5% (40/62).
- Disseminated: Gold Standard Diagnostics MTTT-IgM 100.0% (22/22), Predicate STTT-IgM 100.0% (22/22).
- Late: Gold Standard Diagnostics MTTT-IgM 82.9% (34/41), Predicate STTT-IgM 22.0% (9/41).
- CDC Reference Panel (MTTT):
- Study Type: Testing against a masked characterized serum panel from the CDC for MTTT-IgM.
- Sample Size: 280 positive and negative specimens from CDC.
- Key Results:
- Healthy: Gold Standard Diagnostics MTTT-IgM 100.0% agreement, Predicate STTT-IgM 99.0% agreement.
- Early Lyme: Gold Standard Diagnostics MTTT-IgM 76.7% agreement, Predicate STTT-IgM 50.0% agreement.
- Cardiac Lyme: Gold Standard Diagnostics MTTT-IgM 66.7% agreement, Predicate STTT-IgM 66.7% agreement.
- Neurological Lyme: Gold Standard Diagnostics MTTT-IgM 100.0% agreement, Predicate STTT-IgM 100.0% agreement.
- Late: Gold Standard Diagnostics MTTT-IgM 80.0% agreement, Predicate STTT-IgM 35.0% agreement.
- Look-alike Disease: Gold Standard Diagnostics MTTT-IgM 96.7% agreement, Predicate STTT-IgM 97.8% agreement.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Comparison with Predicate Device:
- Positive percent agreement = 90.3% (93/103)
- Negative percent agreement = 99.6% (460/462)
Second-Tier Testing with Predicate Device:
- 2nd Tier PPA = 98.3% (58/59)
Clinical Sensitivity:
- Early Lyme: 75.9% (44/58)
- Disseminated: 100.0% (17/17)
- Late: 89.7% (35/39)
CDC Panel (Specificities inferred from Healthy population):
- Healthy: 93.0% (Gold Standard Diagnostics IgM ELISA Test Kit)
- Healthy: 86.0% (Predicate IgM ELISA)
MTTT Comparison (Prospective Study):
- Negative percent agreement for second-tier tests = 58.3%
- Positive percent agreement (overall MTTT vs STTT) = 100.0%
- Negative percent agreement (overall MTTT vs STTT) = 95.7%
MTTT Sensitivity Study:
- Early: 62.9% (Gold Standard Diagnostics MTTT – IgM)
- Disseminated: 100.0% (Gold Standard Diagnostics MTTT – IgM)
- Late: 82.9% (Gold Standard Diagnostics MTTT – IgM)
MTTT CDC Reference Panel (Specificities inferred from Healthy population):
- Healthy: 100.0% (Gold Standard Diagnostics MTTT-IgM)
- Healthy: 99.0% (Predicate STTT- IgM)
- Look-alike Disease: 96.7% (Gold Standard Diagnostics MTTT-IgM)
- Look-alike Disease: 97.8% (Predicate STTT- IgM)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3830
Treponema pallidum treponemal test reagents.(a)
Identification. Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 22, 2021
Gold Standard Diagnostics Jennifer Roth Vice President, Product Development 2851 Spafford St. Davis, California 95618
Re: K203295
Trade/Device Name: Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema Pallidum Treponemal Test Reagents Regulatory Class: Class II Product Code: LSR Dated: November 4, 2020 Received: November 9, 2020
Dear Jennifer Roth:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Maria Ines Garcia, Ph.D. Branch Chief Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203295
Device Name
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
Indications for Use (Describe)
The Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit is intended as a qualitative test for the detection of IgM antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. When used as the first-tier screening test, positive and equivocal results must be supplemented through additional testing by one of the following methods:
· Standard two-tier test methodology (STTT) using an IgM blot test following current interpretation guidelines, OR
• Modified two-tier test methodology (MTT) using the Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/ IgM ELISA Test.
The assay can also be used as a second-tier confirmation test using the MTTT methodology when used with the Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test as the first-tier screening test.
Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory findings.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image contains the logo for Gold Standard Diagnostics. The logo features the words "GOLD STANDARD DIAGNOSTICS" stacked on top of each other in a bold, sans-serif font. To the right of the text is a graphic consisting of three overlapping hexagons, outlined in gold.
510(k) Summary
This 510(k) summary is being submitted in accordance with the requirement of SMDA 1990 and 21 CFR 807.92.
- Submitter's Name: Gold Standard Diagnostics Address: 620 Cantrill Drive Davis, CA. 95618 Phone Number: 530-759-8000 Contact Person: Jennifer Roth Date: November 3, 2020
-
- Product and Trade Name: Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
Common Name: Lyme ELISA Test
- Product and Trade Name: Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
Regulation Section:
(21 CFR 866.3830) Treponema pallidum treponemal test reagents.
Classification: Class II
Product Code: LSR; Reagent, Borrelia Serological Reagent
- Note: This clearance is for a modified use (Modified Two-tier Testing or MTTT use) for the previously cleared IVD test, the Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit (K200023). The information and study data for the modified use is presented under the heading of "MTTT Comparison" below. With the exception of the intended use, all other information and data remain the same.
3) Legally Marketed Device to Which the Submitter Claims Equivalence:
- a. STTT Trinity Biotech MarDx Borrelia burgdorferi EIA IgM Test Kit (K894293).
- b. MTTT Gold Standard Diagnostics Borrelia burgdorferi IgM Blot Test Kit (K113846).
4) Description of the Device:
The kit includes 12 x 8 well Antigen Coated strips. Conjugate. Substrate, Stop Solution, Wash Buffer, Diluent, Negative Control, Positive Control, and Cutoff Control. The controls are provided to determine if the assay is functioning properly and to determine the antibody level. The reagents are sufficient for 96 determinations.
During the test procedure, antibodies to B. burgdorferi (sensu stricto) if present in the human serum sample will bind to the antigens coated onto the wells forming antigen-antibody complexes. Excess antibodies are removed by washing. A conjugate of goat anti-human IgM
4
antibodies conjugated with horseradish peroxidase is then added, which binds to the antigenantibody complexes. Excess conjugate is removed by washing. This is followed by the addition of a chromogenic substrate, tetramethylbenzidine (TMB). If specific antibodies to the antigen are present in the patients' serum, a blue color will develop. The enzymatic reaction is then stopped with a stopping solution causing the contents of the well to turn yellow. The wells are read photometrically with a microplate reader at 450nm.
The antigens used in the Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test kit is a combination of B. burgdorferi sensu stricto strain B31 lysate, B. burgdorferi sensu stricto strain 2591 lysate, and a recombinant VlsE from B. burgdorferi sensu stricto strain B31. The lysates use spirochetes growing in BSK-H complete medium until mid-exponential phase. The recombinant VlsE protein is produced in E. coli SURE2 cells and purified by affinity chromatography. The purity of each antigen is assayed by SDS-PAGE followed by Coomassie staining and/or Western blotting.
5) Intended Use of the Device:
The Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit is intended as a qualitative test for the detection of IgM antibodies to B. burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of infection. When used as the first-tier screening test, positive and equivocal results must be supplemented through additional testing bv one of the following methods:
- Standard two-tier test methodology (STTT) using an IgM blot test following current ● interpretation guidelines, OR
- . Modified two-tier test methodology (MTTT) using the Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test.
The assay can also be used as a second-tier confirmation test using the MTTT methodology when used with the Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IzM ELISA Test as the first-tier screening test.
Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory findings.
6) Comparison with the Predicate Device:
The tables below provide a comparison of the Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test kit with the Trinity Biotech MarDx Borrelia burgdorferi EIA IgM Test kit (predicate device: K894293).
| Similarities | ||
|---|---|---|
| Item | Subject Device: Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | Predicate Device: Trinity Biotech MarDx Borrelia burgdorferi EIA IgM Test Kit |
| Intended Use | The Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA | Trinity Biotech MarDx Borrelia burgdorferi EIA IgM Test System is a |
5
| | Test kit is intended as a qualitative
presumptive (first step) test for the
detection of IgM antibodies to B.
burgdorferi sensu stricto in human
serum from symptomatic patients
or people suspected of infection.
Positive and equivocal results
must be supplemented by testing
with a second-step Western blot
assay. | qualitative test intended for use in the
presumptive detection of human IgM
antibodies to Borrelia burgdorferi in
human serum. This EIA system should
be used to test serum from patients with
a history and symptoms of infection with
B. burdorferi. All positive and equivocal
specimens should be retested with a
highly specific, second-tier test such as
Western blot. Positive second-tier
results are supportive evidence of
infection with B. burdorferi. The
diagnosis of Lyme disease should be
made based on history and symptoms
(such as erythema migrans), and other
laboratory data, in addition to the
presence of antibodies to B. burdorferi.
Negative results (either first or second-
tier) should not be used to exclude Lyme
disease. |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Assay Format | Antigen coated microtiter plate -
96 wells. | Same |
| Technology | ELISA | Same |
| Sample Matrix | Human serum | Same |
| Sample Processing | Dilute Samples 1:100 in Diluent | Same |
| Controls Provided | Positive, Cutoff, Negative | Same |
| Reagents Provided | Diluent, Wash, Conjugate,
Substrate, Stop Solution,
Absorption Solution | Same |
| Reported Results | Positive, Equivocal, Negative | Same |
| Interpretation | Optical density readings from
Spectrophotometer | Same |
| Differences | ||
|---|---|---|
| Item | Subject Device: Gold Standard | |
| Diagnostics Borrelia burgdorferi | ||
| IgM ELISA Test Kit | Predicate Device: Trinity Biotech | |
| MarDx Borrelia burgdorferi EIA | ||
| IgM Test Kit | ||
| Volumes | 100ul sample, 50ul substrate, 50ul | |
| stop solution | 100ul sample, 100ul substrate, | |
| 100ul stop solution | ||
| Incubation | 15/15/15 minutes at room | |
| temperature | 30/30/10 minutes at room | |
| temperature | ||
| Antigens | B. burgdorferi B31 strain, | |
| B. burgdorferi 2591 strain, | ||
| B. burgdorferi recombinant VlsE | B. burgdorferi B31 strain | |
| Results Interpretation | Convert to units. | |
| Negative 11.0 | Positive ≥1.2 | |
| -- | ---------------- | --------------- |
| -- | ---------------- | --------------- |
6(b1): Nonclinical Studies:
Determination of the Assav Cutoff
The cutoff was determined by testing a total of 208 normal sera which consisted of 103 sera from an endemic region of Lyme disease and 105 sera from a non-endemic region of Lyme disease. The mean plus two standard deviations was used to determine the assay cutoff. A known positive sample was then diluted to produce a ready to use cutoff control. An additional 194 samples consisting of 114 samples from different phases of Lyme disease, 8 negative healthy samples, 72 negative Lyme disease samples but do have other diseases that may cause serologic cross-reactivity, were tested. A receiver operating characteristics (ROC) analysis was performed to evaluate the performance of the assay and confirm that the chosen cutoff provided the best compromise between sensitivity and specificity.
Precision
To determine the precision of the Borrelia burgdorferi IgM ELISA Test, a within-lab precision study was conducted. A precision panel consisting of a negative sample, a high negative sample, a low positive sample, and a moderate positive sample, along with the kit controls, was tested in-house. Each of the panel members was tested in duplicate, twice per day, for 12 days. The sample panel was masked and randomized. The results are summarized in the following table:
| Sample | N | Mean
Units | | Within-Run | Between-Run | Between-Day | Total |
|----------------------|----|---------------|----|------------|-------------|-------------|-------|
| Moderate
Positive | 48 | 20.6 | SD | 1.234 | 0.476 | 0.423 | 1.222 |
| | | | CV | 6.0% | 2.3% | 2.1% | 5.9% |
| Low
Positive | 48 | 12.4 | SD | 0.849 | 0.728 | 0.405 | 0.834 |
| | | | CV | 6.9% | 5.9% | 3.3% | 6.7% |
| High
Negative | 48 | 5.7 | SD | 0.740 | 0.495 | 0.349 | 0.727 |
| | | | CV | 13.1% | 8.7% | 6.2% | 12.8% |
| Negative | 48 | 2.5 | SD | 0.328 | 0.103 | 0.061 | 0.324 |
| | | | CV | 13.3% | 4.2% | 2.5% | 13.1% |
| Positive
Control | 48 | 25.2 | SD | 1.197 | 0.337 | 0.492 | 1.183 |
| | | | CV | 1.3% | 1.3% | 2.0% | 4.7% |
| Cutoff
Control | 48 | 9.9 | SD | 0.317 | 0.238 | 0.305 | 0.287 |
| | | | CV | 3.2% | 2.4% | 3.1% | 2.9% |
| Negative
Control | 48 | 0.7 | SD | 0.124 | 0.052 | 0.017 | 0.123 |
| | | | CV | 18.1% | 736% | 2.5% | 17.9% |
Reproducibility
A reproducibility panel consisting of a negative sample, a high negative sample, a low positive sample, and a moderate positive sample, along with the kit controls, was tested at three
7
different sites. The sample panel was masked and randomized. Each of the panel members was tested in triplicate, twice per day, for five days. The Within-Run, Between-Run, Between-Days, and Between-Sites Standard Deviation and Coefficients of Variation (CV) were calculated. The results are summarized in the following table:
| Sample | N | Mean
Units | | Within-
Run | Between-
Run | Between-
Day | Between-
Site | Total |
|----------------------|----|---------------|----|----------------|-----------------|-----------------|------------------|-------|
| Moderate
Positive | 90 | 54.4 | SD | 3.26 | 1.37 | 2.49 | 1.38 | 3.73 |
| | | | CV | 6.0% | 2.5% | 4.6% | 2.5% | 6.9% |
| Low
Positive | 90 | 17.1 | SD | 1.13 | 0.46 | 0.98 | 0.78 | 1.29 |
| | | | CV | 6.6% | 2.8% | 5.7% | 4.6% | 7.6% |
| High
Negative | 90 | 6.5 | SD | 0.60 | 0.34 | 0.48 | 0.56 | 0.75 |
| | | | CV | 9.2% | 5.2% | 7.4% | 8.6% | 11.4% |
| Negative | 90 | 1.8 | SD | 0.31 | 0.25 | 0.29 | 0.32 | 0.34 |
| | | | CV | 17.0% | 14.3% | 15.9% | 17.5% | 18.6% |
| Positive
Control | 30 | 24.2 | SD | 1.69 | 1.10 | 1.28 | 0.34 | 1.64 |
| | | | CV | 7.0% | 7.0% | 5.3% | 3.5% | 6.8% |
| Cutoff
Control | 60 | 9.9 | SD | 0.36 | 0.17 | 0.22 | 1.33 | 0.34 |
| | | | CV | 3.6% | 1.7% | 2.2% | 5.5% | 3.4% |
| Negative
Control | 30 | 0.7 | SD | 0.09 | 0.03 | 0.04 | 0.04 | 0.72 |
| | | | CV | 13.3% | 5.1% | 5.1% | 5.0% | 13.1% |
Analytical Specificity
The analytical specificity was determined by testing 208 asymptomatic individuals' samples from endemic and non-endemic regions. The Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test results are summarized in the following table:
| Number of Samples | Number Positive/Equivocal | Analytical Specificity | |
|---|---|---|---|
| Endemic Region | 103 | 4 | 96.1% |
| Non-endemic Region | 105 | 10 | 90.5% |
Cross Reactivity
A study using 277 samples was conducted to evaluate potential cross reactivity from different disease conditions. The samples were obtained from serum vendors who confirmed their positivity for each respective marker. The samples were tested on the Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test. The results are summarized in the following table:
| Infection / Diagnosis | Number of
Sera Tested | # Positive /
(%) |
|--------------------------------|--------------------------|---------------------|
| Tick-borne Relapsing Fever IgM | 21 | 0 / (0%) |
| Treponemal Infections (TPPA) | 29 | 0 / (0%) |
| Rickettsia IgM | 23 | 0 / (0%) |
8
| Ehrlichiosis IgM | 10 | 6 / (60%)* |
|---|---|---|
| Babesiosis IgM | 16 | 10 / (63%)* |
| Leptospirosis IgM | 10 | 8/ (80%)* |
| H. pylori IgM | 10 | 0 / (0%) |
| Epstein-Barr Virus IgM | 14 | 0 / (0%) |
| Varicella Zoster Virus | 16 | 6 / (38%) |
| Fibromyalgia | 25 | 0 / (0%) |
| Rheumatoid Arthritis | 12 | 0 / (0%) |
| Autoimmune Disease | 46 | 0 / (0%) |
| Multiple Sclerosis | 22 | 0 / (0%) |
| Severe Periodontitis | 23 | 0 / (0%) |
*Also positive on the predicate device
Interfering Substances
The effect of potential interfering substances on samples using the Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test was evaluated. Three samples, a high negative, an equivocal and a low positive were spiked with high levels of interferants and were tested along with serum without spiked interferants. The recommended concentrations from the guideline "Interference Testing in Clinical Chemistry" EP07-A3 from the Clinical and Laboratory Standards Institute were used (see table below). The tested substances did not affect the performance of the Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test.
| Substance | Concentration | Interference |
|---|---|---|
| Albumin | 60 mg/ml | None detected |
| Bilirubin | 0.4 mg/ml | None detected |
| Cholesterol | 4.0 mg/ml | None detected |
| Hemoglobin | 10 mg/ml | None detected |
| Triglycerides | 15 mg/ml | None detected |
6(b2): Clinical Studies:
Comparison with Predicate Device
Comparison studies were conducted at three sites (one internal and two external reference laboratories) using prospective samples submitted for Lyme serology testing. Five hundred thirty one (531) serum samples were tested on both the Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test and on the predicate B. burgdorferi IgM ELISA Test. The results are summarized in the following table:
| Predicate IgM ELISA | |||||
|---|---|---|---|---|---|
| Positive | Equivocal* | Negative | Total | ||
| Gold Standard Diagnostics | |||||
| Borrelia burgdorferi IgM | |||||
| ELISA Test Kit | Positive | 72 | 9 | 5 | 86 |
| Equivocal* | 4 | 8 | 5 | 17 | |
| Negative | 1 | 9 | 418 | 428 | |
| Total | 77 | 26 | 428 | 531 |
*Equivocal samples counted as positive
9
| Positive percent agreement = 90.3% (93/103) | 95% CI (82.9% - 95.5%) |
|---|---|
| Negative percent agreement = 99.6% (460/462) | 95% CI (98.5% - 99.9%) |
Second-Tier Testing
All positive and equivocal samples by the Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test and by the Predicate IgM ELISA were tested by a FDA cleared IgM blot assay. The results are summarized in the following table:
| | Tier 1 Positive
or Equivocal | IgM Blot
Positive | IgM Blot
Negative |
|--------------------------------------------------------------------------------------------------------|---------------------------------|----------------------|----------------------|
| Predicate IgM ELISA | 103 | 59 | 44 |
| Gold Standard
Diagnostics Borrelia
burgdorferi IgM
ELISA Test Kit | 103 | 61 | 42 |
| Predicate IgM ELISA
+
Gold Standard
Diagnostics Borrelia
burgdorferi IgM
ELISA Test Kit | 93 | 58 | 35 |
| Percent Agreement with Predicate Device | ||
|---|---|---|
| 2nd Tier PPA | ||
| (95% CI) | 98.3% | |
| (90.9% - 99.9%) | 58/59 |
Clinical Sensitivity
Sensitivity Study
A sensitivity study was performed on 114 clinically characterized samples. The samples encompass early, disseminated, and late stages of Lyme disease. The samples were tested on both the Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test and on the predicate B. burgdorferi IgM ELISA Test. The results are summarized in the following table:
| Disease
Stage | n | Gold Standard
Diagnostics Borrelia
burgdorferi IgM
ELISA Test Kit | Predicate
IgM ELISA |
|------------------|----|----------------------------------------------------------------------------|------------------------|
| Early | 58 | 75.9% (44/58) | 77.6% (45/58) |
| Disseminated | 17 | 100.0% (17/17) | 100.0% (17/17) |
| Late | 39 | 89.7% (35/39) | 84.6% (33/39) |
10
CDC Panel
A panel of 280 positive and negative specimens from the Center of Disease Control (CDC) for Lyme disease detection was tested on both the Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test and on the predicate device. The results are presented as a means to convey further information on the performance of the Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test with a masked characterized serum panel. The results are summarized in the following table:
| | | Gold Standard Diagnostics
Borrelia burgdorferi IgM
ELISA Test Kit | | Predicate
IgM ELISA | |
|-----------------------|-----|-------------------------------------------------------------------------|-------------------------------------------|-----------------------------|-------------------------------------------|
| Disease Stage | n | Positive
or
Equivocal | % Agreement
with Clinical
Diagnosis | Positive
or
Equivocal | % Agreement
with Clinical
Diagnosis |
| Healthy | 100 | 7 | 93.0% | 14 | 86.0% |
| Early Lyme | 60 | 46 | 76.7% | 48 | 80.0% |
| Cardiac Lyme | 3 | 2 | 66.7% | 2 | 66.7% |
| Neurological Lyme | 7 | 7 | 100.0% | 7 | 100.0% |
| Late | 20 | 17 | 85.0% | 17 | 85.0% |
| Look-alike
Disease | 90 | 17 | 81.1% | 25 | 72.2% |
Expected Values
The range of values and positivity rate among different studies and population for the Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test are as follows:
| Unit Results | Qualitative Results | |||||
|---|---|---|---|---|---|---|
| Population | # Samples | Mean | Range | Std. Dev. | # Positive/ Equivocal | % Positive/ Equivocal |
| Normal Endemic | 103 | 3.5 | 0.4 - 10.7 | 2.341 | 4 | 3.9% |
| Normal Non-Endemic | 105 | 4.2 | 0.0 - 15.5 | 3.136 | 10 | 9.5% |
| Prospective Study | 531 | 7.7 | 0.0 - 76.6 | 11.742 | 103 | 19.4% |
| Sensitivity Study | 114 | 32.6 | 0.0 - 81.0 | 21.138 | 96 | 84.2% |
Note: It is recommended that each laboratory determine its own normal range based on the population.
7) Conclusion:
11
From the comparison data, we conclude that the Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test is substantially equivalent to the Trinity Biotech MarDx Borrelia burgdorferi EIA IgM Test kit (predicate device: K894293).
MTTT Comparison:
Comparison with the Predicate Device - MTTT:
The Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit, when used as the firststep or second-step test in combination with the Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit in the Modified Two-tier Testing (MTTT) method, was compared to the Standard Two-tier testing (STTT) method using the predicates Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA (K200023) Test Kit as the first-step test followed by testing all the positive and equivocal results on the Gold Standard Diagnostics Borrelia burgdorferi IgM Blot Test (K113846). Below are tables comparing the two devices.
| Similarities | ||
|---|---|---|
| Item | Subject Device: Gold Standard | |
| Diagnostics Borrelia burgdorferi IgM | ||
| ELISA Test Kit | Predicate Device: Gold Standard | |
| Diagnostics Borrelia burgdorferi | ||
| IgM Blot (K113846) | ||
| Intended Use | The Gold Standard Diagnostics Borrelia | |
| burgdorferi IgM ELISA Test Kit is | ||
| intended as a qualitative test for the | ||
| detection of IgM antibodies to B. | ||
| burgdorferi sensu stricto in human | ||
| serum from symptomatic patients or | ||
| people suspected of infection. When | ||
| used as the first-tier screening test, | ||
| positive and equivocal results must be | ||
| supplemented through additional testing | ||
| by one of the following methods: | ||
| •Standard two-tier test methodology | ||
| (STTT) using an IgM blot test following | ||
| current interpretation guidelines, OR | ||
| •Modified two-tier test methodology | ||
| (MTTT) using the Gold Standard | ||
| Diagnostics Borrelia burgdorferi VlsE- | ||
| OspC IgG/IgM ELISA Test. |
The assay can also be used as a second-
tier confirmation test using the MTTT
methodology when used with the Gold
Standard Diagnostics Borrelia | The Gold Standard Diagnostics
Borrelia burgdorferi B31 IgG Line
Blot Test Kit is intended for the
qualitative detection of IgG antibodies
to B. burgdorferi sensu stricto (B31)
in human serum. This test is intended
for use in testing human serum
samples which have been found
positive or equivocal using an ELISA
or IFA test procedure to provide
supportive evidence of infection with
B. burgdorferi. |
12
| burgdorferi VlsE-OspC IgG/IgM
ELISA Test as the first-tier screening
| test. | ||
|---|---|---|
| Positive test results by either the STTT | ||
| or MTTT methodology are supportive | ||
| evidence for the presence of antibodies | ||
| and exposure to Borrelia burgdorferi , | ||
| the cause of Lyme disease. A diagnosis | ||
| of Lyme disease should be made based | ||
| on the presence of Borrelia burgdorferi | ||
| antibodies, history, symptoms, and other | ||
| laboratory findings. | ||
| Antigens | B. burgdorferi B31 strain, | Same |
| Sample Matrix | Human serum | Same |
| Controls Provided | Positive, Cutoff, Negative | Same |
| Sample Processing | Dilute Samples 1:100 | Same |
| Assay Type | Qualitative | Same |
| Differences | ||
|---|---|---|
| Item | Subject Device: Gold Standard | |
| Diagnostics Borrelia burgdorferi IgM | ||
| ELISA Test Kit | Predicate Device: Gold Standard | |
| Diagnostics Borrelia burgdorferi | ||
| IgM Blot (K113846) | ||
| Assay Format | Antigen coated microtiter plate – 96 | |
| wells. | Nitrocellulose Strips | |
| Reagents Provided | Diluent, Wash, Conjugate, Substrate, | |
| Stop Solution | Diluent/Wash, Conjugate, Substrate | |
| Volumes | 100ul sample, 50ul substrate, 50ul stop | |
| solution | 1500ul sample, 1500ul substrate, | |
| Incubation | 15/15/15 minutes at room temperature | 30/30/10-13 minutes at room |
| temperature | ||
| Interpretation | Optical density readings from | |
| Spectrophotometer | Visual | |
| Results | ||
| Interpretation | Convert to units. | |
| Negative 11.0 | Compare to cutoff band | |
| Reported Results | Positive, Equivocal, Negative | Positive, Negative |
Method Comparison Study – MTTT IgM
The following studies were conducted to determine the performance of the Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test as a first-tier or second-tier assay in the modified two-tier testing (MTTT) methodology.
13
Gold Standard Diagnostics MTTT-IgM ELISA Method Comparison: The Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test was utilized in a MTTT (2-ELISA) protocol with the Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test. The MTTT (2-ELISA) results were compared to the standard two-tier testing (STTT) using the Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA followed by testing all positive and equivocal results on the predicate IgM blot test.
Prospective Study
Comparison studies were conducted at three sites (one internal and two external reference laboratories) using prospective samples submitted for Lyme serology testing. Four hundred eighty-one (481) serum samples were tested on the Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test. A total of 68 positive and equivocal samples were obtained.
In the STTT protocol the samples that were positive or equivocal (n=68) were tested with the predicate B. burgdorferi IgM blot test. In the MTTT protocol the samples (n=68) were tested on a second ELISA, the Gold Standard Diagnostics Borrelia burgdorferi VIsE-OspC IgG/IgM ELISA Test. In the second-tier ELISA test, positive and equivocal results were considered positive.
The results of the second-tier test of the STTT when compared to the second-tier test of the MTTT, including only the samples that were positive in the first tier, are summarized in the following table:
| Predicate IgM Immunoblot | ||||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| Gold Standard Diagnostics | ||||
| Borrelia burgdorferi VlsE- | ||||
| OspC IgG/IgM ELISA | Positive | 20 | 20 | 40 |
| Negative | 0 | 28 | 28 | |
| Total | 20 | 48 | 68 |
Negative percent agreement = 58.3%
o C1 (83.2% - 100.0%) 95% CI (43.2% - 72.4%)
The results of the MTTT when compared to the STTT, including all samples that were part of the prospective study (n=481), are summarized in the following table:
| Predicate STTT- IgM | ||||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| Gold Standard Diagnostics | ||||
| MTTT- IgM | Positive | 20 | 20 | 40 |
| Negative | 0 | 441 | 441 | |
| Total | 20 | 461 | 481 |
Positive percent agreement = 100.0% Negative percent agreement = 95.7%
95% CI (83.2% - 100.0%) 95% CI (93.4% - 97.3%)
14
Sensitivity Study
A sensitivity study was performed on 125 clinically characterized samples. The samples encompass early, disseminated, and late stages of Lyme disease. The samples were tested on both the Gold Standard Diagnostics MTTT-IgM and on the predicate STTT-IgM. The results are summarized in the following table:
| | | Gold Standard Diagnostics
MTTT – IgM | | Predicate
STTT - IgM | |
|------------------|----|-----------------------------------------|-------------------------------------------|-----------------------------|-------------------------------------------|
| Disease
Stage | n | Positive
or
Equivocal | % Agreement
with Clinical
Diagnosis | Positive
or
Equivocal | % Agreement
with Clinical
Diagnosis |
| Early | 62 | 39 | 62.9% | 40 | 64.5% |
| Disseminated | 22 | 22 | 100.0% | 22 | 100.0% |
| Late | 41 | 34 | 82.9% | 9 | 22.0% |
CDC Reference Panel
A panel of 280 positive and negative specimens from the Centers of Disease Control (CDC) for Lyme disease detection was tested on both the Gold Standard Diagnostics MTTT-IgM and on the predicate STTT-IgM. The results are summarized in the following table:
| Disease Stage | n | Gold Standard Diagnostics
MTTT-IgM | | Predicate STTT- IgM | |
|---------------------|-----|---------------------------------------|-------------------------------------------|-----------------------------|-------------------------------------------|
| | | Positive
or
Equivocal | % Agreement
with Clinical
Diagnosis | Positive
or
Equivocal | % Agreement
with Clinical
Diagnosis |
| Healthy | 100 | 0 | 100.0% | 1 | 99.0% |
| Early Lyme | 60 | 46 | 76.7% | 30 | 50.0% |
| Cardiac Lyme | 3 | 2 | 66.7% | 2 | 66.7% |
| Neurological Lyme | 7 | 7 | 100.0% | 7 | 100.0% |
| Late | 20 | 16 | 80.0% | 7 | 35.0% |
| Look-alike Disease* | 90 | 3 | 96.7% | 2 | 97.8% |
*infectious mononucleosis, fibromyalgia, multiple sclerosis, rheumatoid arthritis, syphilis and severe periodontitis
8) Conclusion:
From the comparison data, we conclude that the Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test is substantially equivalent to the Gold Standard Diagnostics Borrelia burgdorferi IgM Blot Test Kit (K113846) when used for the Modified Two-tier Testing (MTTT) Lyme testing.